Local Anesthetic Activity of Liposomal Formulations in Dentistry
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- After topical application of the local anesthetic formulations at the oral mucosa, their influence on pulpal response was assessed by an electrical pulp tester.
研究概览
简要总结
This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated ropivacaine formulations.
详细描述
This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated 1 and 2% ropivacaine gel formulations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics
研究组 & 干预措施
Liposomal ropivacaine, topical
The topical anesthetics were applied at the region of right and left maxillary lateral incisors at the buccal mucosa.
干预措施: Ropivacaine (Drug)
Liposomal ropivacaine, palatal mucosa
Topical formulations were applied at the palatal mucosa at the right canine region and efficacy of topical formulations was accessed through insertion of a 30 gauge needle and injection of anesthetic solution.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
After topical application of the local anesthetic formulations at the oral mucosa, their influence on pulpal response was assessed by an electrical pulp tester.
时间窗: 10 minutes
次要结局
- The efficacy of the topical anesthetics was measured after a simulation of a local anesthesia in the application site (insertion of a 30 gauge needle until periosteum contact).(10 seconds after removal of topical formulation)